International Regulatory Affairs - Senior Manager/Associate Director

Summary

A global biopharmaceutical company is seeking a highly motivated and energetic professional to join its International Regulatory Affairs team. The role will be responsible for developing regulatory strategies, preparing and executing regulatory submissions and post-marketing activities in Japan, and providing regulatory insight and support for clinical development. The position will also serve as a key liaison with Japanese regulatory authorities and collaborate closely with regional and global teams.

Responsibilities

• Develop Japanese regulatory filing strategies and identify potential risks and gating factors.
  
• Lead the strategic planning and preparation of complex regulatory submissions, including new drug applications and post-marketing maintenance activities.
  
• Ensure regulatory submissions are prepared in accordance with applicable Japanese regulations and requirements.
  
• Serve as a primary liaison with Japanese regulatory authorities, including MHLW and PMDA, and support regulatory discussions and negotiations as required.
  
• Lead the preparation for and execution of regulatory agency meetings.
  
• Work closely with cross-functional global teams and international colleagues to align on strategic and operational deliverables.
  
• Monitor and evaluate new and emerging Japanese regulations and guidance, advising internal stakeholders on potential impacts to products and development plans.
  
• Contribute regulatory expertise and strategic input to clinical development activities in Japan.
  

Key Stakeholders

• Japan-based cross-functional teams
  
• APAC Regulatory Affairs
  
• Global Regulatory Affairs and international teams
  
• Global headquarters
  
• Japanese regulatory authorities, including MHLW and PMDA
  

Requirements

• Bachelor’s degree in life sciences or a related field.
  
• Pharmacist qualification is a plus.
  
• Fluency in Japanese and English.
  
• 10+ years of relevant industry experience, including significant Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
  
• Strong knowledge and understanding of the Japanese regulatory environment.
  
• Proven experience preparing, submitting, and obtaining approvals for Japanese regulatory applications.
  
• Thorough understanding of relevant drug development regulations and guidelines.
  
• Strong written and verbal communication, presentation, planning, and coordination skills.
  
• Experience in clinical development and/or strong understanding of clinical development processes is highly desirable.
  
• Strong proficiency with standard business software and tools.
  
• Ability to collaborate effectively with stakeholders across Japan, APAC, and global teams.